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A Population-Based Case-Control Study of Biliary Tract Cancers in Shanghai, China

A Population-Based Case-Control Study of Biliary Tract Cancers in Shanghai, China

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00339560
Enrollment
2624
Registered
2006-06-21
Start date
1997-05-16
Completion date
2008-05-21
Last updated
2020-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Tract Cancer

Keywords

Ampulla of Vater, Gallbaldder, Cancer, Extrahepatic Bile Duct

Brief summary

The key aims of this study include estimation of possible risk associated with a history of gallstones, bacterial infection for the biliary tract, other medical history, diet, use of tobacco and alcohol, obesity, reproductive factors, and family history of cancer. Information will be used to examine risk patterns a) seperately by anatomic subsite; b) among patients with gallbladder cancer vs. controls undergoing cholecystectomy for gallstones; c) among the patients with bile duct cancer vs. Hospital controls without cancer who undergo surgery for removal of bile duct stones. We will also attempt to ascertain reasons for cancer who undergo surgery for removal of bile duct stones. We will also attempt to ascertain reasons for the rising incidence of biliary tract cancers in Shanghai. Serum collected from all subjects will be analyzed for estrogens and other hormones, vitamins C and E, cholesterol, and bacterial antibodies (including salmonella typhi, paratyphi, and escherischia coli). Bile fluid will be cultured for aerobic bacteria, and gallstones analyzed for color, cholesterol, and evidence of bacteria infection. A major challenge in biliary tract cancer research is to determine how cancer risk factors differ from those for gallstones or biliary duct stone disease, since many people have gallstones (or biliary duct stones) but few develop cancer....

Detailed description

The key aims of this study include estimation of possible risk associated with a history of gallstones, bacterial infection for the biliary tract, other medical history, diet, use of tobacco and alcohol, obesity, reproductive factors, and family history of cancer. Information will be used to examine risk patterns a) seperately by anatomic subsite; b) among patients with gallbladder cancer vs. controls undergoing cholecystectomy for gallstones; c) among the patients with bile duct cancer vs. Hospital controls without cancer who undergo surgery for removal of bile duct stones. We will also attempt to ascertain reasons for cancer who undergo surgery for removal of bile duct stones. We will also attempt to ascertain reasons for the rising incidence of biliary tract cancers in Shanghai. Serum collected from all subjects will be analyzed for estrogens and other hormones, vitamins C and E, cholesterol, and bacterial antibodies (including salmonella typhi, paratyphi, and escherischia coli). Bile fluid will be cultured for aerobic bacteria, and gallstones analyzed for color, cholesterol, and evidence of bacteria infection. A major challenge in biliary tract cancer research is to determine how cancer risk factors differ from those for gallstones or biliary duct stone disease, since many people have gallstones (or biliary duct stones) but few develop cancer.

Interventions

None listed

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* INCLUSION CRITERIA: Cases of biliary tract cancer newly diagnosed between September 1, 1996 and August 31, 1999 among residents of urban Shanghai. Must be under the age of 75 at the time of diagnosis.

Design outcomes

Primary

MeasureTime frameDescription
Gallbladder Cancer5 yearsGallbladder cancer

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026